Medical Device Directive (MDD)

Manufacturers of medical devices have a tremendous responsibility to keep end users safe. Therefore, they need to comply with European regulations (93/42/EEC) to ensure that their innovative and continuously developed devices are safe and perform well. DEKRA is designated to review the compliance of products to the essential requirements of the MDD for access to the EU market.

Transition from MDD to MDR

The current MDD is being replaced by the Medical Device Regulations (MDR) which came into force on May 25, 2017. The transitional period will end in 2020. The scope of the MDR has been extended to include additional devices. If you are interested in having devices certified under the MDR by DEKRA, a pre-application is first required. For further information, please contact us from info​.japan@​dekra​.com .